UNITED STATES pATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`12/822,612
`
`ISSUE DATE
`
`02/03/2015
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`8945621
`
`POZN.P0027US
`
`6136
`
`01/14/2015
`
`7590
`108197
`Parker Highlander PLLC
`1120 South Capital of Texas Highway
`Bldg. 1, Suite 200
`Austin, TX 78746
`
`The projected patent number and issue date are specified above.
`
`ISSUE NOTIFICATION
`
`Determination of Patent Term Adjustment under 35 U.S.C. 154 (b)
`(application filed on or after May 29, 2000)
`
`The Patent Term Adjustment is 480 day(s). Any patent to issue from the above-identified application will
`include an indication of the adjustment on the front page.
`
`If a Continued Prosecution Application (CPA) was filed in the above-identified application, the filing date that
`determines Patent Term Adjustment is the filing date of the most recent CPA.
`
`Applicant will be able to obtain more detailed information by accessing the Patent Application Information
`Retrieval (PAIR) WEB site (http://pair.uspto.gov).
`
`Any questions regarding the Patent Term Extension or Adjustment determination should be directed to the
`Office of Patent Legal Administration at (571)-272-7702. Questions relating to issue and publication fee
`payments should be directed to the Application Assistance Unit (AAU) of the Office of Data Management
`(ODM) at (571)-272-4200.
`
`APPLICANT(s) (Please see PAIR WEB site http://pair.uspto.gov for additional applicants):
`
`Brian Ault, Wilmington, DE;
`Clara Hwang, Wilmington, DE;
`Everardus Orlemans, Chapel Hill, NC;
`John R. Plachetka, Chapel Hill, NC;
`Mark Sostek, Wilmington, DE;
`
`The United States represents the largest, most dynamic marketplace in the world and is an unparalleled location
`for business investment, innovation, and commercialization of new technologies. The USA offers tremendous
`resources and advantages for those who invest and manufacture goods here. Through SelectUSA, our nation
`works to encourage and facilitate business investment. To learn more about why the USA is the best country in
`the world to develop technology, manufacture products, and grow your business, visit SelectUSA.gov.
`
`IR103 (Rev. 10/09)
`
`

`
`Application/Control Number: 12/822,612
`Art Unit: 1612
`
`Page 2
`
`Allowable Subject Matter
`
`The following is an examiner's statement of reasons for allowance: Applicants
`
`have demonstrated the unexpected result that patients taking low dose aspirin who
`
`were administered the instantly recited dosage form (PN400) showed a lower incidence
`
`of gastric ulcers than non-aspirin using patients administered PN400 (see instant tables
`
`3 and 5).
`
`Any comments considered necessary by Applicants must be submitted no later
`
`than the payment of the issue fee and, to avoid processing delays, should preferably
`
`accompany the issue fee. Such submissions should be clearly labeled "Comments on
`
`Statement of Reasons for Allowance."
`
`Examiners Amendment
`
`An examiner's amendment to the record appears below. Should the changes
`
`and/or additions be unacceptable to Applicants, an amendment may be filed as
`
`provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be
`
`submitted no later than the payment of the issue fee.
`
`Authorization for this examiner's amendment was given in a telephone interview
`
`with Steven Highlander on 9/16/2014.
`Change(s) applied
`to document,
`/A.C/
`10/22/2014-
`
`The application has been amended as follows:
`
`21
`Claim 1. At line 19, please delete the word [[and]]. At line ~immediately before the
`
`period, please insert the phrase ---and wherein administration of the unit dose form
`
`is more effective at reducing the incidence of the NSAID-associated ulcers in
`
`

`
`c range(s) applied
`t o document,
`ID~M!f9RMATION DISCLOSURE
`/
`1 ~JAJJ;MENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`12822612
`
`2010-06-24
`
`First Named Inventor
`
`I Ault
`
`Art Unit
`
`1614
`
`Examiner Name
`
`I
`Attorney Docket Number
`
`1 03786-US-NP/NS
`
`36
`
`20090074863
`
`2009-03-19
`
`Taneja
`
`37
`
`20100062064
`
`2010-03-11
`
`Ault et al.
`
`38
`
`20100172983
`
`2010-07-08
`
`Plachetka
`
`39
`
`20100178334
`
`2010-07-15
`
`Johansson et al.
`
`40
`
`20120064156
`
`2012-03-15
`
`Plachetka
`
`If you wish to add additional U.S. Published Application citation information please click the Add button. Add
`Remove
`
`FOREIGN PATENT DOCUMENTS
`
`Examiner Cite Foreign Document
`No Number3
`Initial*
`
`Country
`Code2 i
`
`Kind Publication
`Code4 Date
`
`Name of Patentee or
`Applicant of cited
`Document
`
`Pages,Columns,Lines
`where Relevant
`Passages or Relevant
`Figures Appear
`
`T5
`
`1
`
`2139653
`
`2
`
`19801811
`
`3
`
`4035455
`
`4
`
`0005129
`
`CA
`
`DE
`
`DE
`
`EP
`
`1994-12
`
`2004-12-23
`
`Stada Arzneimittel AG
`
`1992-05-14
`
`Byk Gulden Lomberg
`Chemische Fabrik GmbH
`
`1981-04-29
`
`Aktiebolaget Hassle Fack
`
`D
`
`[8]
`
`D
`
`D
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /A.M./
`
`/Adam rv1iiiigan/
`
`09/09/2012
`
`

`
`Form PT0-1449 (modified)
`
`List of Patents and Publications for Applicant's
`
`Atty. Docket No.:
`PZAZ.P0002US
`Applicant:
`Brian AULT et al.
`
`Page 1 of 4
`
`I Serial No.:
`
`12/822,612
`
`INFORMATION DISCLOSURE STATEMENT
`
`(Use several sheets if necessary)
`
`U.S. Patent Documents
`See Page I
`
`Filing Date:
`June 24,2010
`Foreign Patent Documents
`SeePage2
`
`I Group:
`1612
`Other Art
`See Pages 2-4
`
`Exam.
`I nit.
`
`Ref.
`Des.
`
`Change(s) aoolied
`t,
`to documen
`/D.H.F /
`+
`11/13/201
`
`AI
`
`A2
`
`A3
`
`A4
`
`AS
`
`A6
`
`A7
`
`A8
`
`A9
`
`U.S. Patent Documents
`Name
`Date
`
`11/01101
`
`11/22/01
`
`Scott eta!.
`
`Gelber eta!.
`
`08115/02
`I...V':;J;..<:;RJ=,h_k::
`
`=r~ v~
`
`Bergman et al.
`l
`.
`'LUULD
`epm eta.
`
`Document
`Number
`
`2001-00364 73
`
`2001-0044410
`
`2002-0111370
`
`2002-0155153
`
`2002-0160046
`
`10/31102
`
`Robinson et al.
`
`2003-0040537
`
`02/27/03
`
`Plachetka et al.
`
`2003-0129235
`
`07/10/03
`
`2003-0232876
`
`12/18/03
`
`Chen et al.
`
`Plachetka
`
`2004-0022846
`
`02/05/04
`
`Depui et at.
`
`2004-0 180089
`
`09116/04
`
`Plachetka et a!.
`
`Class
`
`Sub
`Class
`
`Filing Date
`of App.
`
`424
`
`514
`
`514
`
`424
`
`424
`
`514
`
`424
`
`514
`
`424
`
`424
`
`463
`
`27
`
`338
`
`452
`
`469
`
`406
`
`470
`
`419
`
`452
`
`4
`
`04/17/01
`
`01/05/01
`
`12/20/01
`
`03/04/02
`
`11/21101
`
`09/26/02
`
`10/28/02
`
`04116/03
`
`07/17/03
`
`AIO
`
`All
`
`A12
`
`A13
`
`A14
`
`A15
`
`A16
`
`Al7
`
`Al8
`
`Al9
`
`A20
`
`A21
`
`2005-0249811
`
`11/10/05
`
`Plachetka
`
`2006-0177504
`
`08/10/06
`
`Sudharadas
`
`2007-0207200
`
`09/06/07
`
`Plachetka et al.
`
`2009-0297594
`
`5,690,960
`
`5,872,145
`
`6,060,499
`
`6,126,816
`
`7,030,162
`
`7,060,694
`
`7,332,183
`
`12/03/09
`
`11/25/97
`
`02/16/99
`
`05/09/00
`
`10/03/00
`
`04/18/06
`
`06/13/06
`
`02/19/08
`
`Depui et al.
`
`Bengtsson et al.
`
`P1achetka
`
`Plachetka
`
`Ruiz Jr.
`
`Plachetka et al.
`
`Plachetka et a!.
`
`Plachetka et a!.
`
`424
`
`424
`
`424
`
`424
`
`424
`
`514
`
`514
`
`210
`
`514
`
`514
`
`424
`
`472
`
`488
`
`451
`
`451
`
`480
`
`415
`
`415
`
`95
`
`619
`
`177
`
`472
`
`12/22/03
`
`05/16/05
`
`02/08/06
`
`03/02/07
`
`02/09/09
`
`09/27/94
`
`08/14/97
`
`09/11198
`
`07/14/99
`
`09/26/02
`
`10/29/02
`
`12/22/03
`
`{00044203}
`
`EXAMINER:
`
`/Adam Milligan/
`
`DATE CONSIDERED:
`
`07/10/2013
`
`EXAMINER: INITIAL IF REFERENCE CONSIDERED, WHETHER OR NOT CITATION IS IN CONFORMANCE WITH MPEP609; DRAW LINE THROUGH
`CITATION IF NOT IN CONFORMANCE AND NOT CONSIDERED. INCLUDE COPY OF THIS FORM WITH NEXT COMMUNICATION TO APPLICANT.
`
`

`
`PA.RT B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissioner for Patents
`P.Oo Box 1450
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`(571)-273-2885
`
`or Fax
`
`INSTRllCTIONS: This forrn should be used for transmitting the ISSUE FEE and PUBLICATION FEE (if required)" Blocks l through 5 should be completed where
`appropn,1te .. All furt..~er correspondence including the Patent, advance orders and notification of maintenance fees \viH be n1,1:ded to the current correspondence address as
`indicated unless corrected below or directed otherwise in Block 1, by (a) specifying a new CfJrrespondence address; and/or (b) indicating a separate '1:;EE A.DDRESS:! for
`rnaintenance fee notifications.
`
`ClJRRENT CORRESPONDENCE ADDRESS (Note: Use Block 1 fGr cmy chJ11ge of Jcic'•Te::s)
`
`09/25/20 l4
`
`759G
`108197
`Parker Highlander PLLC
`1120 South Capital of Texas High\vay
`Bldg" l, Suite 200
`Austin, TX 78746
`
`Nc•te: A. certificate of mailing can only be used for domestic rnailings of the
`f<ee(s) Transrnitt,lL Th:ts certJficate cannot he used for any other accon1panying
`paper.s. Each o.a .. kl.it~onal p51per:-..such as an a~si~nment or forrnal drawing, nnlst
`have 1ts own cert1f1cate of maJung or transnl!SSJon.
`
`Certi!1cate of Mailing or Transmission
`I hereby certify that this Fee(s,l Transrnittal is being deposited \vjth the United
`Stale'; Postal Service with sufficient pmtage for first class mail in an envelope
`addressed to the Jv1ail Stop lSS1JE FEE address above, or being facsirrdJe
`transmitted to L.'le USPTO (571) 273-2885, on the date indicated below_
`
`Steven L. Hiqhiander
`/Steven L Hiqhlander/
`Decernber -16, 20-14
`
`(Signature!
`
`(Date!
`
`APPLICATION NO"
`
`F!Lll'iG DATE
`
`Flc'<.ST NAMED INVENTOR
`
`ATTORNEY DOCKET NO"
`
`CONFIRMATION NO"
`
`l2/8?.?.,6J 2
`
`06/24/2010
`
`Brian Ault
`
`POZJ"\f.P0027lJS
`
`6136
`
`TITLE OF INVENTION: Method for Treating a Patient at Risk for Developing an NSAID-associaled lllcer
`
`APPLN.TYPE
`
`ENTITY STATTJS
`
`ISSTJE FEE DUE
`
`nonprovi ;ional
`
`UNDISCOUNTED
`
`$960
`
`PUBLICATION FEE DUE PREV" PAID ISSUE FEE
`so
`
`$0
`
`TOTAL FEE(Sl DTJE
`
`DATE DUE
`
`$960
`
`12/26/2014
`
`EXAMINlOR
`
`ARTTJNJT
`
`CI"ASS-STJBCLASS
`
`MILLIGAN_ ADlv\1 C
`
`1612
`
`424-,172000
`
`Change of correspondence address or indication of !oFee Address'! (37
`CFR LJ63)"
`"
`'
`0 Change of _c?rrespondence address (or Change of Correspondence
`Address torm PTO/SB/122) att.1ched_
`0 "Fee Addres•;'' indication (or "Fee Address'' Indication form
`PTOiSB/47; Rev 03-02 or more recent) attached_ Ust' of a Customc:r
`Number is required,
`
`2. For printing on the patent front page, Hst
`0) The n,1mes of up to 3 regJstered patent ,1ttorneys
`or agents OR, alternatively,
`(2) The narne of a sjn2le finn (havjruz as a rnernber a
`regio:tered attorney or~agent) and the~ names of up to
`2 registered patent attorneys or agents. Jf no narne is
`listed, no name will be printed"
`
`Parker Highlander PLLC
`
`3_
`
`3_ ASSIGJ'<'EE NAl\IIE i"-'"iD RESIDENCE DATA TO BE PRINTED ON THE PATENT (print or type)
`PLEASE _NlYJE: UnJess an assignee is jdentifjed below, no assjgnee data \VHl appear on the patent. Jf an assignee js identified below, the docurnent has been fHed for
`recordation as •;et forth in 37 CFR J_ J J _ Completion of this form is NOT a substitute for filing an assignmenL
`(A) NANIE OF ASSIGNEE
`(B) RESlDENCE: (CITY and STATE OR C01JNTRY)
`Chapel Hill, NC
`POZEN INC.
`Deerfield, IL
`HORIZON PHARMA USA, INC.
`Please check the .1ppropnate ,1ssignee c,1tegory or categories (will not be printed on the patent): 0 Individual ~ Corpor,ltion or other private group entity 0 Government
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`4a_ The following fee( s) are subm;tted:
`fKl Issue Fee
`0 Publication Fee (No small emily discount pennitted)
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`
`:5. Change in Entity Status (from status indicated above)
`0 Applicant certifying micro entity status" See 37 CFR L29
`0 AppHcant assert:tng smnU entity status. See 37 CI:<R J .27
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`
`4b_ Payment ofFee(s): (Plea;,., fh·;;t reapply any pn~viously paid issut' ft'e shown ahow}
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`Page 2 of 3
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`

`
`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`12822612
`
`24-Jun-201 0
`
`Title of Invention:
`
`Method for Treating a Patient at Risk for Developing an NSAID-associated
`Ulcer
`
`First Named Inventor/Applicant Name:
`
`Brian Ault
`
`Filer:
`
`Steven Lee Highlander/Richard Ortiz
`
`Attorney Docket Number:
`
`POZN.P0027US
`
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`Post-Allowance-and-Post-Issuance:
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`Utility Appllssue Fee
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`1501
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`1
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`960
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`960
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`960
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`

`
`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`20978176
`
`12822612
`
`International Application Number:
`
`Confirmation Number:
`
`6136
`
`Title of Invention:
`
`Method for Treating a Patient at Risk for Developing an NSAID-associated
`Ulcer
`
`First Named Inventor/Applicant Name:
`
`Brian Ault
`
`Customer Number:
`
`108197
`
`Filer:
`
`Steven Lee Highlander/Richard Ortiz
`
`Filer Authorized By:
`
`Steven Lee Highlander
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`Attorney Docket Number:
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`POZN.P0027US
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`24-JUN-201 0
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`File Listing:
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`1
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`POZNP0027US_Applicants-
`Response.pdf
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`

`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In reApplication of: Brian AULT et al.
`
`Group Art Unit: 1612
`
`Serial No.: 12/822,612
`
`Examiner: Adam C. Milligan
`
`Filing Date: June 24, 2010
`
`Attorney Docket No.: POZN.P0027US
`
`Title: METHOD FOR TREATING A
`PATIENT AT RISK FOR
`DEVELOPING AN NSAID(cid:173)
`ASSOCIATED ULCER
`
`Confirmation No.: 6136
`
`CERTIFICATE OF ELECTRONIC TRANSMISSION
`
`I hereby certify that this correspondence is being electronically filed with the
`United States Patent and Trademark Office via EFS-Web on the date below:
`
`December 16.2014
`Date
`
`/Steven L. Highlander/
`Steven L. Highlander
`
`APPLICANT'S RESPONSE TO EXAMINER'S STATEMENT OF REASONS FOR
`ALLOWANCE
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`Commissioner:
`
`This submission is in response to the examiner's statement of reasons for allowance
`
`("Statement"), mailed on September 25, 2014, regarding the captioned application. According to
`
`the Statement, "Applicants have demonstrated the unexpected result that patients taking low dose
`
`aspirin who were administered the instantly recited dosage form (PN400) showed a lower
`
`incidence of gastric ulcers than non-aspirin using patients administered PN400 (see instant tables
`
`3 and 5)." Applicants are unclear as to the scope of this comment, and thus cannot agree with the
`
`Statement, for example because Applicants have demonstrated many different unexpected results
`
`{00200810}
`
`1
`
`

`
`in the present disclosure related to the administration of the claimed pharmaceutical composition
`
`in unit dosage form to patients taking low dose aspirin (LDA). While the Examiner has pointed
`
`to a single unexpected result, the claims are indeed supported by other unexpected results as
`
`well, which are not necessarily explicitly recited in the claims. That said, Applicants can agree
`
`that unexpected results have been demonstrated for the claimed methods of reducing the
`
`incidence of NSAID-associated gastric ulcers in patients taking LDA who are at risk of
`
`developing such ulcers.
`
`Respectfully submitted,
`
`/Steven L. Highlander/
`
`Steven L. Highlander
`Reg. No. 37,642
`Attorney for Applicants
`
`Parker Highlander PLLC
`1120 S. Capital of Texas Highway
`Building One, Suite 200
`Austin, Texas 78746
`512-334-2900 (Telephone)
`512-334-2999 (Fax)
`
`Date: December 16, 2014
`
`{00200810}
`
`2
`
`

`
`UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/822,612
`
`06/24/2010
`
`BrianAu1t
`
`POZN.P0027US
`
`6136
`
`10114/2014
`
`7590
`108197
`Parker Highlander PLLC
`1120 South Capital of Texas Highway
`Bldg. l, Suite 200
`Austin, TX 78746
`
`EXAMINER
`
`MILLIGAN, ADAM C
`
`ART UNIT
`
`PAPER NUMBER
`
`1612
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`10/14/2014
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`docket@phiplaw.com
`
`PTOL-90A (Rev. 04/07)
`
`

`
`UNITED STATES DEPARTMENT OF COMMERCE
`U.S. Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`APPLICATION NO./
`CONTROL NO.
`12/822,612
`
`FILING DATE
`
`24 June, 2010
`
`FIRST NAMED INVENTOR I
`PATENT IN REEXAMINATION
`AULTET AL.
`
`ATTORNEY DOCKET NO.
`
`POZN.P0027US
`
`Parker Highlander PLLC
`1120 South Capital of Texas Highway
`Bldg. 1, Suite 200
`Austin, TX 78746
`
`EXAMINER
`
`ADAM C. MILLIGAN
`
`ART UNIT
`
`PAPER
`
`1612
`
`20141008
`
`DATE MAILED:
`
`Please find below and/or attached an Office communication concerning this application or
`proceeding.
`
`Applicant's representitive informed examiner that there was an error in the consideration of an IDS submitted 8/28/2012. Specifically,
`the last two pages of the IDS were deleted. Accordingly, Examiner has now considered the IDS in full and attached the considered
`IDS hereto.
`
`Commissioner for Patents
`
`/ADAM C MILLIGAN/
`Primary Examiner, Art Unit 1612
`
`PT0-90C (Rev.04-03)
`
`

`
`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`12822612
`
`2010-06-24
`
`First Named Inventor
`
`I Ault
`
`Art Unit
`
`1614
`
`Examiner Name
`
`I
`Attorney Docket Number
`
`1 03786-US-NP/NS
`
`Panara et al., "Effects of the novel anti-inflammatory compounds, N-[2-( cyclohexyloxy)-4-nitrophenyl]
`methanesulphonamide (NS-398) and 5-methanesulphonamido-6-(2,4-difluorothio-phenyl)-1-inda none (L-745,337), on D
`the cyclo-oxygenase activity of human blood prostaglandin endoperoxide synthases," British Journal of Pharmacology,
`116, pp. 2429-2434 (1995)
`
`Pang et al., "Modeling of intestinal drug absorption: roles of transporters and metabolic enzymes (for the Gillette review D
`series)" Drug Metabolism and Disposition, 31(12), pp_ 1507-1519 (2003)
`
`Patrono, et al., "Low-Dose Aspirin for the Prevention of Atherothrombosis," New Eng. J. Med., 353, pp. 2373-2383
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`113-120 ( 1 985)
`
`Pirmohamed et al., "Adverse drug reactions as cause of admission to hospital: prospective analysis of 18,820
`patients," Br. Med. J., 329, pp_ 15-19 (2004)
`
`Porter S.C., "Coating of Pharmaceutical Dosage Forms," in: A. Gennaro (Ed.), Remington: the Science and Practice of D
`Pharmacy, 19th ed., pp_ 1650-1651 (1995)
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`Omeprazole and Comparison with Dissolution Findings," Pharmaceutical Research, 11(11), pp_ 1669-1672 (1994)
`
`Raskin, et al., "Misoprostol Dosage in the Prevention of Nonsteroidal Anti-Inflammatory Drug-Induced Gastric and
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`
`D
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`
`Richardson et al., "Proton pump inhibitors, pharmacology and rationale for use in gastrointestinal disorders," Drugs, 56 D
`(3), PP- 307-335 (1998)
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`
`Robinson, et al., "Effects of Ranitidine Gastroduodenal Mucosal Damage Induced by Nonsteroidal Anti-inflammatory D
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`10/08/2014
`/Adam MilliQan/
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /A.M./
`
`

`
`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`12822612
`
`2010-06-24
`
`First Named Inventor
`
`I Ault
`
`Art Unit
`
`1614
`
`Examiner Name
`
`I
`Attorney Docket Number
`
`1 03786-US-NP/NS
`
`12
`
`Roth, et al., "Cimetidine Therapy in Nonsteroidal Anti-inflammatory Drug Gastropathy: Double-blind Long-term
`Evaluation," Arch_ Intern_ Med., 147, pp_ 1798-1801 (1987)
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`D
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`Rubinstein, "Gastrointestinal anatomy physiology and permeation pathways," Enhancement in Drug Discovery, CRC D
`Press, pp_ 3-35 (2007)
`
`14
`
`Sangiah et al., "Effects of misoprostol and omeprazole on basal gastric pH and free acid content in horses," Res_ Vet D
`Sci_, 47(3), pp_ 350-354 (1989)
`
`15
`
`Savarino et al., "Effect of one-month treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) on gastric pH of
`rheumatoid arthritis patients," Digestive Diseases and Sciences, 43, pp_ 459-463 (1998)
`
`D
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`16
`
`Scarpignato et al., Gastroenterology International; Pages 186-215 (1999)
`
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`
`17
`
`Scheiman et al., "NSAID-induced peptic ulcer disease: a critical review of pathogenesis and management," Dig_ Dis., D
`12, pp_ 210-222 (1994)
`
`18
`
`Scheiman et al., "Omeprazole ameliorates aspirin-induced gastroduondenal injury," Digestive Diseases and Sciences, D
`39(1), pp_ 97-103 (1994)
`
`19
`
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`
`D
`
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`
`Scott and Sundell, "Inhibition of H+K+ ATPase by SCH 28080 and SCH 32651 ,"European Journal of Pharmacology, D
`112, pp_ 268-270 (1985)
`
`21
`
`Seitz et al., "Tablet coating," in The theory and practice of industrial pharmacy, Lachman et al. eds., Lea and Febiger, D
`PP- 346-373 (1986)
`
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`
`Selway et al., "Potential hazards of long-term acid suppression," Scand_ J. Gastroenterol., 25, Supp_ 178, pp_ 85-92
`(1990)
`
`/Adam Milligan/
`
`1 0/08i20i 4
`
`D
`
`EFS Web 2.1-17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /A.M./
`
`

`
`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`12822612
`
`2010-06-24
`
`First Named Inventor
`
`I Ault
`
`Art Unit
`
`1614
`
`Examiner Name
`
`I
`Attorney Docket Number
`
`1 03786-US-NP/NS
`
`23
`
`Sharma et al., "Comparison of 24-hour intragastric pH using four liquid formulations of lansoprazole and omeprazole," D
`Am_ J. Health-Syst Pharm., 56, Supp_ 4, pp_ S18-S21 (1999)
`
`24
`
`Silverman, The Organic Chemistry of Drug Design and Drug Action, 2nd Edition, Academic Press, pp_ 102 & 527
`(2004)
`
`D
`
`25
`
`Silverstein et al., "Gastrointestinal toxicity with celecoxib vs_ nonsteroidal anti-inflammatory drugs for osteoarthritis and D
`rheumatoid arthritis; the CLASS study: A randomized controlled trial," JAMA, 284, pp_ 1247-1255 (2000)
`
`26
`
`Silverstein, et al., "Misoprostol Reduces Serious Gastrointestinal Complications in Patients with Rheumatoid Arthritis D
`Receiving Nonsteroidal Anti-Inflammatory Drugs," Ann_ Intern_ Med., 123(4), pp_ 241-249 (1995)
`
`27
`
`Simon English translation ----Simon, et al., "Schutzwirkung von Omeprazol gegenuber niedrig dosierter
`Acetylsalicylsaure," Arzneimittel Forschung, 45, pp_701-703 (1995)
`
`D
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`
`Simon, et al., "Schutzwirkung von Omeprazol gegenuber niedrig dosierter Acetylsalicylsaure," Arzneimittel Forschung, D
`45, pp_ 701-703 (1995)
`
`29
`
`Sung, "Management of nonsteroidal anti-imflammatory drug-related peptic ulcer bleeding," Am. J. Med., 110(1A), pp_ D
`29S-32S (2001)
`
`30
`
`Tronstad et al., "Gastroscopic findings after treatment with enteric-coated and plain naproxen tablets in healthy
`subjects," Scand_ J. Gastroenterol., 20, pp_ 239-242 (1985)
`
`31
`
`Vane, et al., "The future of NSAID therapy: selective COX-2 inhibitors," IJCP, 54(1 ), pp.7-9 (JanJFeb_ 2000)
`
`32
`
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`
`D
`
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`
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`
`33
`
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`
`von Unge et al., "Stereochemical assignment of the enantiomers of omeprazole from X-ray anaylysis of a
`fenchyloxymethyl derivative of (+)-(R)- omeprazole," Tetrahedron, 8(12), pp_ 1967-1970 (1997)
`10/08/2014
`/Adam Milliaan/
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /A.M./
`
`D
`
`

`
`IN FORMATION DISCLOSURE
`STATEMENT BY APPLICANT
`( Not for submission under 37 CFR 1.99)
`
`Application Number
`
`Filing Date
`
`12822612
`
`2010-06-24
`
`First Named Inventor
`
`I Ault
`
`Art Unit
`
`1614
`
`Examiner Name
`
`I
`Attorney Docket Number
`
`1 03786-US-NP/NS
`
`34
`
`Wagner et al., "Effects of nonsteroidal anti-inflammatory drugs on ulcerogenesis and gastric secretion in pylorus-
`ligated rat," Digestive Diseases and Sciences, Vol. 40, pgs_ 134-140 (1995)
`
`35
`
`Wakitani et al., "Profile of JTE-522 as a human cyclooxygenase-2 inhibitor," Jpn_ J. Pharmacol., 78, pp_ 365-371
`(1998)
`
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`
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`
`Wallmark et al., "The relationship between gastric acid secretion and gastric H.sup.+, K.sup_+-ATPase activity," J. Bioi. D
`Chern., 260(25), pp_ 13681-13684 (1985)
`
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`
`Warner, et al., "Nonsteroid drug selectivities for cyclo-oxygenase-1 rather than cyclo-oxygenase-2 are associated with D
`human gastrointestinal toxicity: A full in vitro analysis," Proc_ Natl. Acad_ Sci. USA, 96, pp_ 7563-7568 (Jun_ 1999)
`
`38 Weil et al., "Prophylactic aspirin and risk of peptic ulcer bleeding," Br. Med_ J., 310, pp_ 827-830 (1995)
`
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`(1999)
`
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`WOLFE, et al., "Acid Suppression: Optimizing Therapy for Gastroduodenal Ulcer Healing, Gastroesophageal Reflux D
`Disease, and Stress Related Erosive Syndrome," Gastroenterology, 118(2), pp_ S9-S31 (2000)
`
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`
`Yeomans et al., "A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal anti-inflammatory D
`drugs," N_ Engl. J. Med., 338, pp_ 719-726 (1998)
`
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`
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`Med., 104, pp_ 56S-61 S (1998)
`
`If you wish to add additional non-patent literature document citation information please click the Add button Add
`
`EXAMINER SIGNATURE
`
`Examiner Signature I
`
`iAdam Milligan/
`
`I
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered. Include copy of this form with next communication to applicant.
`
`I Date Considered
`
`i Oi08/2014
`
`EFS Web 2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH. /A.M./
`
`

`
`UNITED STA 1ES p A 1ENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`NOTICE OF ALLOWANCE AND FEE(S) DUE
`
`09/25/2014
`
`108197
`7590
`Parker Highlander PLLC
`1120 South Capital of Texas Highway
`Bldg. 1, Suite 200
`Austin, TX 78746
`
`EXAMINER
`
`MILLIGAN, ADAM C
`
`ART UNIT
`
`PAPER NUMBER
`
`1612
`
`DATE MAILED: 09/25/2014
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`12/822,612
`
`06/24/2010
`
`BrianAult
`
`POZN.P0027US
`
`6136
`
`TITLE OF INVENTION: Method for Treating a Patient at Risk for Developing an NSAID-associated Ulcer
`
`APPLN. TYPE
`
`ENTITY STATUS
`
`ISSUE FEE DUE
`
`PUBLICATION FEE DUE PREV. PAID ISSUE FEE
`
`TOTAL FEE(S) DUE
`
`DATE DUE
`
`nonprovisional
`
`UNDISCOUNTED
`
`$960
`
`$0
`
`$0
`
`$960
`
`12/26/2014
`
`THE APPLICATION IDENTIFIED ABOVE HAS BEEN EXAMINED AND IS ALLOWED FOR ISSUANCE AS A PATENT.
`PROSECUTION ON THE MERITS IS CLOSED. THIS NOTICE OF ALLOWANCE IS NOT A GRANT OF PATENT RIGHTS.
`THIS APPLICATION IS SUBJECT TO WITHDRAWAL FROM ISSUE AT THE INITIATIVE OF THE OFFICE OR UPON
`PETITION BY THE APPLICANT. SEE 37 CFR 1.313 AND MPEP 1308.
`
`THE ISSUE FEE AND PUBLICATION FEE (IF REQUIRED) MUST BE PAID WITHIN THREE MONTHS FROM THE
`MAILING DATE OF THIS NOTICE OR THIS APPLICATION SHALL BE REGARDED AS ABANDONED.
`THIS
`STATUTORY PERIOD CANNOT BE EXTENDED. SEE 35 U.S.C. 151. THE ISSUE FEE DUE INDICATED ABOVE DOES
`NOT REFLECT A CREDIT FOR ANY PREVIOUSLY PAID ISSUE FEE IN THIS APPLICATION.
`IF AN ISSUE FEE HAS
`PREVIOUSLY BEEN PAID IN THIS APPLICATION (AS SHOWN ABOVE), THE RETURN OF PART B OF THIS FORM
`WILL BE CONSIDERED A REQUEST TO REAPPLY THE PREVIOUSLY PAID ISSUE FEE TOWARD THE ISSUE FEE NOW
`DUE.
`
`HOW TO REPLY TO THIS NOTICE:
`
`I. Review the ENTITY STATUS shown above. If the ENTITY STATUS is shown as SMALL or MICRO, verify whether entitlement to that
`entity status still applies.
`If the ENTITY STATUS is the same as shown above, pay the TOTAL FEE(S) DUE shown above.
`If the ENTITY STATUS is changed from that shown above, on PART B- FEE(S) TRANSMITTAL, complete section number 5 titled
`"Change in Entity Status (from status indicated above)".
`For purposes of this notice, small entity fees are 112 the amount of undiscounted fees, and micro entity fees are 112 the amo